Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
155353–155376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1984
MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM
K834215 · GZJ
Th Charters, Inc.
Neurology · 29d
Cleared Jan 01, 1984
DRUG STANDARDS
K833276 · DKB
Supelco, Inc.
Toxicology · 101d
Cleared Dec 30, 1983
PRE-ROLLED TUBULAR STOCKINETTE
K831936
Ormed Mfg., Inc.
General & Plastic Surgery · 198d
Cleared Dec 30, 1983
STRATUS THEOPHYLLINE ASSAY
K832965 · KLS
American Dade
Chemistry · 120d
Cleared Dec 30, 1983
DERMA STRIP-TM SKIN CLOSURES
K833083 · FPX
Howmedica Corp.
General & Plastic Surgery · 109d
Cleared Dec 30, 1983
LASER PROTECTIVE EYESHIELD
K833232 · HQF
Stefanovsky & Assoc.
Ophthalmic · 115d
Cleared Dec 30, 1983
SELECTO-DISC NOVOBIOCIN 5UG
K833407 · JTO
Lab Ability, Inc.
Microbiology · 91d
Cleared Dec 30, 1983
IMAGE INTENSIFIER TUBE W/HOUSING &
K833641 · JAA
Varian Assoc., Inc.
Radiology · 74d
Cleared Dec 30, 1983
TEE ADAPTER 9890-FLUSH WINDING 282
K833693 · JKS
Shaban Mfg. Co.
Chemistry · 73d
Cleared Dec 30, 1983
CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK
K833709 · JTN
General Diagnostics
Microbiology · 71d
Cleared Dec 30, 1983
ELASTIC BREATHABLE OVER-WRAP BANDAGE
K833729 · NAD
American Medical Disposable, Inc.
General & Plastic Surgery · 66d
Cleared Dec 30, 1983
BTI BIOX III OXIMETER CRITICAL CAREUNI
K833826 · DQA
Biox Technology, Inc.
Anesthesiology · 65d
Cleared Dec 30, 1983
HAEMOPHILUS IDENTIFICATION TEST KIT
K833963 · JTO
Remel Co.
Microbiology · 44d
Cleared Dec 30, 1983
10B
K833968 · JSN
Remel Co.
Microbiology · 44d
Cleared Dec 30, 1983
SABOURAUD DEXTROSE AGAR
K834008 · JSJ
Micro Media Laboratories
Microbiology · 39d
Cleared Dec 30, 1983
PVP IODINE
K834022 · JTO
Remel Co.
Microbiology · 38d
Cleared Dec 30, 1983
BIO-ORNITHINE
K834028 · JTO
Remel Co.
Microbiology · 38d
Cleared Dec 30, 1983
BIO-UREA
K834029 · JTO
Remel Co.
Microbiology · 38d
Cleared Dec 29, 1983
LOW TRAUMA ARTERIAL FILTER H-640
K831507 · DTM
C.R. Bard, Inc.
Cardiovascular · 232d
Cleared Dec 29, 1983
PLEURAL DRAINAGE SYS #PDS-100-4
K831849 · CAC
American Bentley
Hematology · 204d
Cleared Dec 29, 1983
JP-2 RESPIRATORY MONITORING SYSTEM
K832005 · CCK
Morgan Associates, Inc.
Anesthesiology · 189d
Cleared Dec 29, 1983
SOLUTION ADMIN. SET 2C9096 W/10 PVC
K832284 · FPA
Travenol Laboratories, S.A.
General Hospital · 169d
Cleared Dec 29, 1983
USE OF TWEEN 80 AS A WETTING AGENT ON
K832802 · DTN
American Bentley
Cardiovascular · 133d
Cleared Dec 29, 1983
FLOW-PAC GGT REAGENT SET
K833029 · JQB
American Research Products Co.
Chemistry · 113d